Belinostat (PXD 101) is a Class I and II HDAC inhibitor that is being studied in multiple clinical trials as a single agent or in combination with chemotherapeutic agents for the treatment of various hematological and solid cancers.
The primary objective of the study is to evaluate the safety of belinostat in combination with Tarceva and to generate efficacy data in terms of progression-free survival, response rate and overall survival in patients with NSCLC.
Belinostat in peripheral t-cell lymphoma has been granted fast track designation by the FDA.
The open-label and prospective Phase I/II trial will enroll up to 35 patients and is supported by Spectrum’s partner Topotarget, a Scandinavia-based international biotech company headquartered in Denmark, dedicated to developing cancer therapies.
Spectrum Pharmaceuticals MD, chairman, CEO and president Rajesh Shrotriya said preclinical data has demonstrated synergy between belinostat and Tarceva.
"We look forward to the results of this Phase I/II trial with Tarceva, which is an FDA-approved oral drug for advanced NSCLC," Shrotriya said.